Inflammatory Diseases Clinical Trial
Official title:
A Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Ascending Doses in Healthy Subjects, an Open-label Study to Assess the Relative Bioavailability and Food Effect of a Tablet Formulation of AZD6793 in Healthy Subjects and a Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Tablet Formulation of AZD6793 in Patients With Chronic Obstructive Pulmonary Disease
The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD) [Part 1] and Multiple Ascending Dose (MAD) [Part 2] in healthy subjects. Additionally, the study will include Part 3 (bioavailability and food effect cohort) to assess the relative oral bioavailability between film-coated tablet and oral suspension (reference formulation) as well as the effect of a high fat high calorie (HFHC) meal on the PK of AZD6793 film-coated tablet, in comparison to fasting conditions, after a single oral dose of AZD6793 in healthy subjects.
The study will be conducted at a single study centre and comprises of 3 parts. Parts 1, 2, and 3 will serve as SAD, MAD, bioavailability and food effect, respectively. Part 1 of the study will comprise: - A Screening Period of maximum 28 days (Day -29 to Day -2) - A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 (the day before IMP administration [Day 1]) until at least 72 hours after IMP administration. Subjects will then be discharged on Day 4 if in good health and after all samples have been collected. Depending on the emerging data, the length of the stay at the Clinical Unit may be changed. - A Follow-up Visit within 6 ± 1 days after the IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted). Part 2 of the study will comprise: - A Screening Period of maximum 28 days (Day -29 to Day -2). - A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 (the day before first IMP administration [Day 1]) until Day 10. Subjects will receive a single dose of IMP in the morning on Day 1. After a washout of at least 48 hours (depending on PK data from Part 1), subjects will be dosed twice daily (12 hours apart) from Day 3 through Day 7. Subjects will receive the last dose of IMP in the morning of Day 8. Subjects will then be discharged on Day 10 if in good health and after all samples have been collected. - A Follow-up Visit within 6 ± 1 days after the last IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted). Part 3 of the study will comprise: - A Screening Period of maximum 28 days (Day -29 to Day -2). - A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 until Day 3. Subjects will be randomised on Day 1 of Visit 3 to one of 3 treatment sequences and will receive AZD6793 on Day 1 of each treatment period. Dose administration will be separated by a washout period of at least 3 days from the previous IMP dose of each treatment period. - A Follow-up Visit within 6 ± 1 days after the last IMP dose ;
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